Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Reconsolidation_NIMH_2012 | Other Identifier | Other |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall aim of this project is to determine if using a cue to trigger (and reactivate) the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in patients with a fear of flying. The long term goals are to establish if targeting the reconsolidation of fear with a reminder of the fear is effective for human clinical populations in reducing relapse (return of fear). In this investigation, the investigators propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality exposure therapy (VRE). All patients in the study will receive exactly the same exposure treatment using a virtual airplane.
Prior to each VRE session, the investigators will test a brief, easy-to-implement manipulation that triggers the fear memory and presumably allows it to be changed in a way that prevents the fear from returning later (i.e., prevents relapse). The investigators propose to randomly assign eligible participants to 1 of 2 conditions: 1) VRE therapy preceded by a reminder of the feared stimulus (a VR clip of a virtual airplane taxiing and taking off) presented 10 minutes prior to all VRE therapy sessions, or 2) VRE therapy preceded by a neutral cue (a VR clip of a virtual living room) presented 10 minutes prior to all VRE therapy sessions. Participants will be evaluated pre- and post-treatment and at a 3 month and 6 month follow-up visit to assess long-term effects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reactivation + VRE | Experimental | Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions |
|
| Neutral Cue + VRE | Active Comparator | VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Exposure Therapy | Behavioral | Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment. |
| Measure | Description | Time Frame |
|---|---|---|
| Fear of Flying Inventory (FFI) | a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment. | Post treatment (9 weeks) |
| The Questionnaire on Attitudes Toward Flying (QAF) | assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99. | post treatment (9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The Beck Depression Inventory (BDI) | a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression. | post-treatment (9 weeks) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara O Rothbaum, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30306 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Reactivation + VRE | Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment. |
| FG001 | Neutral Cue + VRE | VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reactivation + VRE | Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fear of Flying Inventory (FFI) | a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment. | Posted | Mean | Standard Deviation | units on a scale | Post treatment (9 weeks) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reactivation + VRE | Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Rothbaum | Emory University | 404-712-8866 | brothba@emory.edu |
Not provided
| ID | Term |
|---|---|
| C000719189 | Aerophobia |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| D007171 | Implosive Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| State Trait Anxiety Inventory- State (STAI-State) | The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation. | post-treatment (9 weeks) |
| State Trait Anxiety Inventory- Trait (STAI-Trait) | The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation. | post-treatment (9 weeks) |
| Neutral Cue + VRE |
VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. |
|
|
| Primary | The Questionnaire on Attitudes Toward Flying (QAF) | assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99. | Posted | Mean | Standard Deviation | units on a scale | post treatment (9 weeks) |
|
|
|
| Secondary | The Beck Depression Inventory (BDI) | a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression. | Posted | Mean | Standard Deviation | units on a scale | post-treatment (9 weeks) |
|
|
|
| Secondary | State Trait Anxiety Inventory- State (STAI-State) | The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation. | Posted | Mean | Standard Deviation | units on a scale | post-treatment (9 weeks) |
|
|
|
| Secondary | State Trait Anxiety Inventory- Trait (STAI-Trait) | The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation. | Posted | Mean | Standard Deviation | units on a scale | post-treatment (9 weeks) |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Neutral Cue + VRE | VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions. | 0 | 44 | 0 | 44 |
Not provided
Not provided
Not provided